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Background: The introduction of the diagnosis of complex posttraumatic stress disorder (CPTSD) by ICD-11 is a turning point in the field of traumatic stress studies. It’s therefore important to examine the validity of CPTSD in refugee groups exposed to complex trauma (CT) defined as a repeated, prolonged, interpersonal traumatic event. Objective: The objective of this study was to compare DSM-5 and ICD-11 post-traumatic stress disorder diagnoses and to evaluate the discriminant validity of ICD-11 PTSD and CPTSD constructs in a sample of treatment-seeking refugees living in Italy. Method: The study sample included 120 treatment-seeking African refugees living in Italy. All participants were survivors of at least one CT. PTSD and CPTSD diagnoses were assessed according to both DSM-5 and ICD-11 criteria. Results: Findings revealed that 79% of the participants met the DSM-5 criteria for PTSD, 38% for ICD-11 PTSD and 30% for ICD-11 CPTSD. Generally, ICD-11 CPTSD items evidenced strong sensitivity and negative predictive power, low specificity and positive predictive power. Latent class analysis results identified two distinct groups: (1) a PTSD class, (2) a CPTSD class. None of the demographic and trauma-related variables analysed was significantly associated with diagnostic group. On the other hand, the months spent in Italy were significantly associated with PCL-5 score. Conclusions: Findings extend the current evidence base to support the discriminant validity of PTSD and CPTSD amongst refugees exposed to torture and other gross violations of human rights. The results suggest also that, in the post-traumatic phase, the time spent in a ‘safe place’ condition contributes to improve the severity of post-traumatic symptomatology, but neither this variable nor other socio-demographic factors seem to contribute to the emergence of complex PTSD. Further investigations are needed to clarify which specific vulnerability factors influence the development of PTSD or CPTSD in refugees exposed to complex trauma.

Abstract Background Life-threatening streptococcal sepsis nowadays represents an uncommon event in previously healthy infants and children. Critically ill patients suffering from severe streptococcal sepsis complications may present with pre-antibiotic era clinical pictures and require a timely clinical approach to achieve restitutio ad integrum. Results We report a series of four patient groups affected by an uncommon life-threatening streptococcal sepsis, each of them exhibiting some distinct features. Streptococcus Agalactiae sepsis was associated with cerebral thrombotic/ischaemic lesions, whereas severe cardiogenic shock was prominent in the Streptococcus Viridans group; Streptococcus Faecalis and β-hemolytic group A Streptococcus patients mostly reported lung complications. Conclusions Previous antibiotic treatments should not delay aggressive treatment in the intensive care setting. Early diagnostic suspicion, as well as appropriate and aggressive treatment provided within an intensive care setting are crucial for the clinical outcome.

Background: NATALEE assessed efficacy and tolerability of 3 years of adjuvant ribociclib plus NSAI compared with a nonsteroidal aromatase inhibitor (NSAI) alone in a broad population of patients with HR+/HER2- early breast cancer, including a select group without nodal involvement. This is the final preplanned analysis of invasive disease-free survival (iDFS)., Patients and Methods: Premenopausal/postmenopausal women and men were randomized 1:1 to ribociclib (n=2549; 400 mg/day, 3 weeks on/1 week off for 36 months) plus NSAI (letrozole 2.5 mg/day or anastrozole 1 mg/day for 60 months) or NSAI alone (n=2552). Men and premenopausal women also received goserelin (3.6 mg once every 28 days). Patients had anatomical stage IIA (N0 with additional risk factors or N1), IIB, or III disease. The primary endpoint was iDFS. Secondary efficacy endpoints were recurrence-free survival (RFS), distant DFS (DDFS), and overall survival (OS). This final iDFS analysis was planned after ≈500 events., Results: At data cutoff (21 July 2023), ribociclib was stopped for 1996 patients (78.3%); 1091 (42.8%) completed 3 years of ribociclib, and ribociclib treatment was ongoing for 528 (20.7%). Median follow-up for iDFS was 33.3 months. Overall, 226 and 283 iDFS events occurred with ribociclib plus NSAI vs NSAI alone, respectively. Ribociclib plus NSAI demonstrated significant iDFS benefit over NSAI alone (Hazard Ratio 0.749, 95% Confidence Interval [CI] 0.628-0.892; P=0.0012). The 3-year iDFS rates were 90.7% (95% CI 89.3%-91.8%) vs 87.6% (95% CI 86.1%-88.9%). A consistent benefit was observed across prespecified subgroups, including stage (II/III) and nodal status (+/-). DDFS and RFS favored ribociclib plus NSAI. OS data were immature. No new safety signals were observed., Conclusions: With longer follow-up and most patients off ribociclib, NATALEE continues to demonstrate iDFS benefit with ribociclib plus NSAI over NSAI alone in the overall population and across key subgroups. Observed adverse events remained stable., (Copyright © 2024. Published by Elsevier Ltd.)

Oncologists and cancer patients generally agree that the primary goals of advanced cancer treatment are to lengthen and/or improve patient survival. Yet over the last two decades, clinical trials of new cancer treatments have moved away from measuring outcomes that matter to patients. Increasingly, new drugs for advanced cancer treatment reach the market by demonstrating improvements in surrogate endpoints such as progression-free survival (PFS), which is not a measure of how a patient feels, functions, or survives. Research has shown that when patients are fully informed about the meaning of PFS, about half would not choose additional treatment for any magnitude of gain in PFS in the absence of an overall survival improvement. It's time to get back to designing trials that answer clinically meaningful questions and measure the outcomes that truly matter to patients. Engaging educated patient advocates in meaningful ways in clinical trial design and reporting would be a step in this direction., Competing Interests: Neither author has any conflicts of interests to report., (© 2024 The Authors.)

This work aims to shed light on the differential diagnosis of complex post-traumatic stress disorder (cPTSD), post-traumatic stress disorder (PTSD), and borderline personality disorder (BPD) within the context of intimate partner violence (IPV), which represents a highly innovative field of clinical research. To this end, a critical review of the literature was conducted to identify and compare the clinical patterns and symptomatic overlaps among cPTSD, PTSD, and BPD, with an emphasis on their manifestation in both IPV victims and offenders. The results show that despite some symptomatic similarities, cPTSD, PTSD, and BPD have distinct clinical patterns of interpersonal violence. Specifically, disturbances in self-organization (DSO) are more commonly found in offenders, while the diagnosis of cPTSD seems more aligned with the psychological functioning of victims. In addition, cPTSD and specific characteristics of BPD, such as fear of rejection and instability of identity, constitute risk factors for IPV victimization. cPTSD is shown as a predisposing factor not only for IPV victims but also for offenders, while PTSD emerges as a consequential factor. The specific pathways linking PTSD, cPTSD, and BPD with IPV have significant implications for clinical practice. Further research is needed to understand these profiles and the mechanisms linking trauma-related features to IPV, which is crucial for implementing effective violence prevention programs.

Background: Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear., Methods: In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy., Results: As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P = 0.003). Secondary end points - distant disease-free survival and recurrence-free survival - also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals., Conclusions: Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.)., (Copyright © 2024 Massachusetts Medical Society.)

[Correction Notice: An Erratum for this article was reported online in Psychological Trauma: Theory, Research, Practice, and Policy on May 08 2023 (see record 2023-69929-001). In the original article, paragraphs 1 through 3 of the main text and the first paragraph under "PTSD and CPTSD Symptoms" in the Methods section were rewritten to avoid text similarity with that of a previously published article "Evidence of Distinct Profiles of ICD-11 Post-Traumatic Stress Disorder (PTSD) and Complex PTSD in a South African Sample," by James Rink and Gosia Lipinska (European Journal of Psychotraumatology, 2020, Vol. 11, No. 1, Article 1818965, https:// doi.org/10.1080/20008198.2020.1818965). All versions of this article have been corrected.] Objective: This study investigated ICD-11 posttraumatic stress disorder (PTSD) and complex PTSD (CPTSD) symptom profiles and their premigration, postmigration, and demographic predictors in a treatment-seeking sample of asylum-seekers in Agadez (Niger)., Method: Participants were 126 asylum-seekers hosted in a large, isolated reception camp in the desert surroundings of Agadez (humanitarian site) or in a number of small urban hosting facilities ( cases de passages ) who completed measures of trauma exposure and PTSD/CPTSD symptoms. Latent class analysis (LCA) was used to identify symptom profiles, and predictors of class membership were identified via multinomial logistic regression., Results: More asylum seekers met the criteria for CPTSD (74.6%) than PTSD (19.8%) and no gender differences were observed. LCA results identified two distinct groups: (a) a CPTSD class (69.0%); and (b) a PTSD class (31.0%). Membership in the CPTSD class was significantly predicted by the early age of the first traumatic event, levels of functional impairment and reception conditions. Specifically, those in the CPTSD class were more likely to live in the humanitarian site compared with those in the PTSD class., Conclusion: This study supported the validity of the ICD-11 construct of CPTSD in an asylum-seeker sample living in a low-income country. Moreover, the findings suggest that not only premigration factors (i.e., the early age of the first trauma) but also postmigration stressors (i.e., precarious reception conditions in large, isolated facilities) are important predictors of CPTSD symptoms with important implications regarding reception policies and the prevention of trauma-related mental disorders in asylum seekers and refugees. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Background: Ribociclib has demonstrated a statistically significant overall survival benefit in pre- and postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer. New Adjuvant Trial with Ribociclib [LEE011] (NATALEE) is a trial evaluating the efficacy and safety of adjuvant ribociclib plus endocrine therapy (ET) versus ET alone in patients with HR+/HER2- early nonmetastatic breast cancer (EBC)., Methods/design: NATALEE is a multicenter, randomized, open-label, Phase III trial in patients with HR+/HER2- EBC. Eligible patients include women, regardless of menopausal status, and men aged ⩾18 years. Select patients with stage IIA, stage IIB, or stage III disease (per the anatomic classification in the AJCC Cancer Staging Manual , 8th edition) with an initial diagnosis ⩽18 months prior to randomization are eligible. Patients receiving standard (neo)adjuvant ET are eligible if treatment was initiated ⩽12 months before randomization. Patients undergo 1:1 randomization to ribociclib 400 mg/day (3 weeks on/1 week off) +ET (letrozole 2.5 mg/day or anastrozole 1 mg/day [investigator's discretion] plus goserelin [men or premenopausal women]) or ET alone. Ribociclib treatment duration is 36 months; ET treatment duration is ⩾60 months. The primary end point is invasive disease-free survival., Discussion: The 36-month treatment duration of ribociclib in NATALEE is extended compared with that in other adjuvant cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor trials and is intended to maximize efficacy due to longer duration of CDK4/6 inhibition. Compared with the 600-mg/day dose used in advanced breast cancer, the reduced ribociclib dose used in NATALEE may improve tolerability while maintaining efficacy. NATALEE includes the broadest population of patients with HR+/HER2- EBC of any Phase III trial currently evaluating adjuvant CDK4/6 inhibitor treatment., Trial Registration: ClinicalTrials.gov identifier: NCT03701334 (https://clinicaltrials.gov/ct2/show/NCT03701334)., Competing Interests: Dr. Slamon reports stock ownership from BioMarin, Pfizer, Amgen, Seattle Genetics, TORL BioTherapeutics, 1200 Pharma; travel support from BioMarin, Pfizer, Novartis; personal fees from Novartis, Eli Lilly; grants from Pfizer, Novartis; founder of 1200 Pharma, TORL BioTherapeutics. Dr. Fasching reports personal fees from Novartis, Pfizer, Daiichi Sankyo, AstraZeneca, Eisai, MSD, Lilly, Pierre Fabre, Seagen, F. Hoffmann-La Roche, Hexal, Agendia, Sanofi, Gilead; institutional funding from BioNTech, Pfizer, Cepheid; research grant from Pfizer. Dr. Hurvitz has nothing to disclose. Dr. Chia reports personal fees and grants to institution from Novartis, Pfizer, F. Hoffmann-La Roche, Eli Lilly. Prof. Crown has nothing to disclose. Dr. Martín reports personal fees from Lilly, Pfizer, AstraZeneca, Novartis, Roche/Genentech, GSK, PharmaMar, Taiho Oncology; research grants from Novartis, Roche-Genentech. Dr. Barrios reports institutional research grants from Pfizer, PharmaMar, Polyphor, Henlius Biotech, Shanghai, Merck KGaA, Millennium, LEO Pharma, ImClone Systems, Exelixis, Medivation, Asana Biosciences, AB Science, Abraxis Biosciences, Daiichi Sankyo, Bristol Myers Squibb, BioMarin, Astellas Pharma, AbbVie, Merck (MSD), Merrimack, Mylan, Taiho Pharmaceutical, Sanofi, GSK, Roche/Genentech, Lilly, Boehringer Ingelheim, Novartis, AstraZeneca, Amgen, Pfizer; personal fees from Boehringer Ingelheim, Sanofi, Lilly, Zodiac, AstraZeneca, MSD, Bayer, Eisai, Roche/Genentech, Pfizer, Novartis, GSK, Daiichi Sankyo; stock from MEDSIR, Thummi. Dr. Bardia reports research grants to institution from Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics, Mersana, Innocrin; personal fees from Biothermostics, Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Spectrum Pharma, Taiho, Sanofi, Daiichi Sankyo, Puma. Dr. Im reports personal fees from AstraZeneca, Novartis, Hanmi, Pfizer, Eisai, Amgen, Roche, Lilly, GSK, MSD; research grants from AstraZeneca, Pfizer, Eisai, F. Hoffmann-La Roche, Daewoong Pharmaceuticals. Dr. Yardley reports research funding to institution from Daiichi Sankyo/Lilly, Eisai, Roche/Genentech, Novartis, AbbVie, AstraZeneca, Clovis Oncology, Immunomedics, InventisBio, Lilly, MedImmume, Medivation, Merck, Oncothyreon, Pfizer, Syndax, Tesaro; personal fees from Biotheranostics, Bristol Myers Squibb, Celgene, Daiichi Sankyo/Lilly, Eisai, Roche/Genentech, Novartis, NanoString Technologies. Dr. Untch has nothing to disclose. Dr. Huang reports grants to institution from Novartis, Daiichi Sankyo, AstraZeneca, EirGenix, Eli Lilly, MSD, OBI Pharma, Pfizer, F. Hoffmann-La Roche; personal fees from Novartis, Daiichi Sankyo, AstraZeneca, Eli Lilly, Pfizer, F. Hoffmann-La Roche; nonfinancial support from AstraZeneca, EirGenix, Eli Lilly, OBI Pharma, Roche, Novartis. Dr. Stroyakovskii has nothing to disclose. Dr. Xu reports personal fees from Novartis, AstraZeneca, Pfizer, Roche, Eisai. Dr. Moroose reports personal fees from Gilead, Lilly, Pfizer, Seagen, Genentech, Johnson & Johnson. Dr. Loi reports research funding grants to institution from Novartis, Bristol Myers Squibb, Merck, Puma Biotechnology, Eli Lilly, Nektar Therapeutics, AstraZeneca, Roche/Genentech, Seagen; uncompensated consultant for Seagen, Novartis, Bristol Myers Squibb, Merck, AstraZeneca, Eli Lilly, Pfizer, Gilead Therapeutics, Roche/Genentech; consultant with fees paid to institution from Aduro Biotech, Novartis, GSK, Roche/Genentech, AstraZeneca, Silverback Therapeutics, G1 Therapeutics, PUMA Biotechnologies, Pfizer, Gilead Therapeutics, Seagen, Daiichi Sankyo, Merck, Amunix, Tallac Therapeutics, Eli Lilly, Bristol Myers Squibb. Ms. Visco has nothing to disclose. Ms. Bee-Munteanu has nothing to disclose. Ms. Afenjar has nothing to disclose. Dr. Fresco reports other advising institution is contracted by Novartis as CRO conducting the NATALEE trial. Dr. Taran, Dr. Chakravartty, Dr. Zarate, Dr. Lteif report employment and stock ownership. Dr. Hortobagyi reports personal fees and grants to institution from Novartis., (© The Author(s), 2023.)

The term voice hearing (VH) refers to the experience of hearing voices in the absence of corresponding external stimuli and is considered a hallucinatory experience. According to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5; American Psychiatric Association [APA], 2013), hallucinations are perception-like experiences that occur without an external stimulus. They are vivid and clear, with the full force and impact of normal perceptions, and not under voluntary control. Specifically, auditory hallucinations involve the perception of sound, most frequently of voices (i.e., auditory verbal hallucinations- AVHs) but sometimes of clicks or other noises, that are not restricted to the period of awakening or the onset of sleep. AVHs are usually experienced as voices, whether familiar or unfamiliar, that are perceived as distinct from the individual's own thoughts.

Complex dissociative disorders (CDD) include dissociative identity disorder (DID) and the most common other specified dissociative disorder (OSDD, type 1). While consensus-based treatments for CDD are lacking in several international guidelines, patients suffering from CDD show high levels of impairment, treatment utilization and costs. Migrants and refugees often present risk factors for trauma-related and dissociative disorders and need effective and culturally adapted treatments. Schema Therapy (ST) is an integrative psychotherapy that has been recently proposed as a treatment for CDD. This case study examined the process of individual ST, in a three phases-based approach, with a 38-year-old male Yemeni refugee with OSDD, type 1, posttraumatic stress disorder and borderline personality disorder. The treatment was provided in a Western country and the setting included two Western therapists (co-therapy) and an Arabic interpreter/cultural mediator. We assessed the patient's change by using self-report assessments of dissociative and PTSD symptoms, cognitive schemas over 2-year and 4-months treatment periods and a 6-months follow-up. Posttreatment and follow-up reliable change analyses showed significant improvements in dissociative and PTSD symptoms as well as in some cognitive schemas. Despite any firm conclusion cannot be drawn due to the limitations of this study (i.e., single case study), the findings suggest that ST integrated in a phase-oriented approach may be an effective treatment for CDD. Additionally, our study provides some preliminary elements about cross-cultural validity of the schema modes construct as well as cross-cultural effectiveness of ST. More research based on larger samples and specific cross-cultural focused design is needed to confirm these assumptions.

Background and Objectives: Depressive states represent a normal and physiological response to the experience of loss. However, it is possible to identify some elements that allow distinguishing physiological depressive states from pathological ones. Over the years, research has confirmed that a stable tendency to negative self-evaluation is a transdiagnostic factor that triggers and amplifies dysfunctional emotional reactivity, thus contributing to the shift from normal to pathological reaction. In this sense, the secondary problem, or meta-emotional problem , referring to the negative evaluation of one's depressive state and the consequent dysfunctional attempts to solve it, seems to play an important role. The aim of the present study is to investigate how dysfunctional beliefs and the evaluations of depressive symptoms ( meta-emotional problems ) are related to depression severity. Methods: We asked to a community sample to focus on the depressive symptoms they regard as most distressful and evaluate them through specific questionnaires. One-hundred and eighty nine participants were asked to complete a set of questionnaires: (1) the Meta-Emotional Problem Questionnaire; (2) the Center for Epidemiologic Studies Depression Scale; (3) the Beck Depression Inventory; (4) the Dysfunctional Attitude Scale-24 in order to investigate the relation between dysfunctional beliefs, meta-emotional problems, and depressive symptoms severity. Results: Our results show that higher levels of depression are associated both to more pervasive dysfunctional attitudes and increased evaluation of meta-emotional problem . In addition, we conduct a regression analysis to disentangle the impact of the two different measures of depressive symptoms (i.e., BDI-II and CES-D) with two explanatory variables (dysfunctional attitudes and meta-emotional problem ). Results show that meta-emotional problem remains a significant and robust predictor of the severity of depressive symptomatology, while dysfunctional beliefs has a rather weak and non-significant relation with the criterion. In other words, meta-emotional problem consistently explains the higher variance of depressive symptoms than dysfunctional beliefs. In conclusion, our study shows a clear link between meta-emotional problem and depression severity. This is relevant for clinical practice, as it highlights the importance of specifically targeting beliefs about the depressive condition in cognitive-behavioral treatment of depression, since they represent crucial factors maintaining depressive symptomatologies., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Visco-Comandini, Gragnani, Giacomantonio, Romano, Petrucci and Mancini.)

Background: Despite the empirical and clinical relevance of understanding posttraumatic stress disorder (PTSD) heterogeneity in refugees and asylum-seekers, very few studies have examined the manner in which PTSD symptoms manifest in such populations., Aims: This study sought to investigate patterns and predictors of DSM-5 PTSD in a treatment-seeking sample of African refugees., Methods: Participants were 122 African refugees and asylum-seekers living in Italy who completed measures of trauma exposure and PTSD symptoms. Latent class analysis (LCA) was used to identify PTSD symptom profiles, and predictors of class membership were identified via multinomial logistic regression., Results: Among participants, 79.5% had a probable diagnosis of PTSD. Three PTSD classes were identified by LCA: Pervasive (32.0%) with high probabilities of all symptoms, high-Threat (45.9%) with higher probabilities of intrusions and avoidance symptoms, moderate-Avoidance (22.1%) with high probability of thoughts/feelings avoidance. None of the examined variables (legal status, gender, age, education, months spent in Italy, number of traumatic events, employment) significantly predicted class membership with the relevant exception of reception conditions. Specifically, living in large reception centres (over 1,000 people) significantly predicted Pervasive PTSD class membership compared to high/Threat PTSD class and to moderate/Avoidance class., Conclusion: This study provides evidence for distinct patterns of PTSD symptomatology in refugees and asylum seekers. We identified three classes which present both qualitative and quantitative differences in symptoms: Pervasive class, high-Threat class and a new moderate class, characterised by avoidance symptoms. Reception conditions contributed to the emergence of the Pervasive PTSD profile characterised by the symptoms highest severity. These findings highlight that stressors in the post-migration environment, as inadequate reception conditions in large facilities, may have detrimental effect on refugees' mental health. We emphasise the importance for host countries to implement reception models that provide effective protection and integration to this vulnerable population.

Most of the trials investigating the role of transcatheter aortic valve implantation (TAVI) across various strata of risk categories have excluded patients with bicuspid aortic stenosis (BAS) due to its anatomical complexities. The aim of this study was to perform a meta-analysis with meta-regression of studies comparing clinical, procedural, and after-procedural echocardiographic outcomes in BAS versus tricuspid aortic stenosis (TAS) patients who underwent TAVI. We searched the PubMed and Cochrane databases for relevant articles from the inception of the database to October 2019. Continuous and categorical variables were pooled using inverse variance and Mantel-Haenszel method, respectively, using the random-effect model. To rate the certainty of evidence for each outcome, we used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach. Nineteen articles were included in the final analysis. There was no difference in the risk of 30-day mortality, 1-year mortality, 30-day cardiovascular mortality, major and/or life-threatening bleeding, major vascular complications, acute kidney injury, permanent pacemaker implantation, device success, annular rupture, after-procedural aortic valve area, and mean pressure gradient between the 2 groups. BAS patients who underwent TAVI had a higher risk of 30-day stroke, conversion to surgery, need for second valve implantation, and moderate to severe paravalvular leak. In conclusion, the present meta-analysis supports the feasibility of TAVI in surgically ineligible patients with BAS. However, the incidence of certain procedural complications such as stroke, conversion to surgery, second valve implantation, and paravalvular leak is higher among BAS patients compared with TAS patients, which must be discussed with the patient during the decision-making process., Competing Interests: Disclosures The authors declare no conflicts of interest. Note: All authors had access to the data and a role in writing the manuscript. The present work was conducted at New York Medical College, Metropolitan Hospital Centre., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Chest pain is one of the most common reasons for emergency department visits worldwide, and troponins play a central role in diagnosing acute coronary syndrome (ACS) in these patients. Hence, the tests for these molecules are imperative in triage for ACS. Presently, multiple high-sensitivity troponin tests are available, including those for troponin T and I. However, in the presence of physiological and pathological alterations such as chronic kidney disease (CKD) and muscle dysfunction, these tests lose their sensitivity and specificity, especially if not interpreted in the right clinical background. Further, no guidelines exist for interpreting the results in patients with CKD. We identified studies that compared the relative efficacy, sensitivity, and specificity of tests for troponin T and I in patients with CKD to understand the practical problems in the clinical interpretation of these results in the specific setting of CKD and highlight the measures to be taken into consideration., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: During the Coronavirus disease 2019 (COVID-19) pandemic, advanced health systems have come under pressure by the unprecedented high volume of patients needing urgent care. The impact on mortality of this "patients' burden" has not been determined., Methods and Findings: Through retrieval of administrative data from a large referral hospital of Northern Italy, we determined Aalen-Johansen cumulative incidence curves to describe the in-hospital mortality, stratified by fixed covariates. Age- and sex-adjusted Cox models were used to quantify the effect on mortality of variables deemed to reflect the stress on the hospital system, namely the time-dependent number of daily admissions and of total hospitalized patients, and the calendar period. Of the 1225 subjects hospitalized for COVID-19 between February 20 and May 13, 283 died (30-day mortality rate 24%) after a median follow-up of 14 days (interquartile range 5-19). Hospitalizations increased progressively until a peak of 465 subjects on March 26, then declined. The risk of death, adjusted for age and sex, increased for a higher number of daily admissions (adjusted hazard ratio [AHR] per an incremental daily admission of 10 patients: 1.13, 95% Confidence Intervals [CI] 1.05-1.22, p = 0.0014), and for a higher total number of hospitalized patients (AHR per an increase of 50 patients in the total number of hospitalized subjects: 1.11, 95%CI 1.04-1.17, p = 0.0004), while was lower for the calendar period after the peak (AHR 0.56, 95%CI 0.43-0.72, p<0.0001). A validation was conducted on a dataset from another hospital where 500 subjects were hospitalized for COVID-19 in the same period. Figures were consistent in terms of impact of daily admissions, daily census, and calendar period on in-hospital mortality., Conclusions: The pressure of a high volume of severely ill patients suffering from COVID-19 has a measurable independent impact on in-hospital mortality., Competing Interests: The authors have declared that no competing interests exist.